Earlier this month, EPA released for public comment a new white paper on probabilistic risk assessment, marking the Obama Administration’s first major foray into the contentious debate about EPA's evolving risk assessment methods. Back in May, EPA Administrator Lisa Jackson announced changes to the way the Office of Research and Development (ORD) will update risk assessments for the IRIS database, but that announcement was made without any real public input and it only implicated the inner workings of one program office (albeit an important one). The public comment period on the new white paper presents the first opportunity for the various stakeholders who usually weigh in on EPA’s risk assessment policies to have some say in the new administration’s policies.
The new white paper, Using Probabilistic Methods to Enhance the Role of Risk Analysis in Decision Making, focuses on one of the fundamental problems in regulatory risk assessment – how should risk assessors and risk managers address the uncertainty and variability intrinsic to the risk assessment process?
The most straightforward way to answer that question, and EPA’s approach in many situations, is to use default assumptions. When the pesticides program staff is working on setting a limit for pesticide residue on apples, they can use a standard assumption about the number of apples a person eats. Or when ORD staff updates IRIS profiles, they can assume a linear dose-response relationship for a suspected carcinogen’s toxicity. But as scientific knowledge about certain parameters and models used in risk assessments grows, default assumptions might legitimately be replaced by data collected in the real world. Recognizing that every parameter and model used in a risk assessment has some inherent level of uncertainty, and that variability in the population can have a significant impact on risk determinations, risk assessors can use probabilistic data to replace point estimates of specific parameters or generic model assumptions.
Full textOn Monday, the big news out of FDA was the announcement that they’re going to publish a new assessment of the risks posed by BPA in food packaging, due out by the end of November. Jesse Goodman, FDA’s Chief Scientist, made the announcement at a meeting of the agency’s Science Board, which also heard two presentations by scientists from different offices within FDA working on the new assessment.
Last year, FDA formed a task force to assess the risks of BPA and the task force quickly concluded that “there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects.” Given the rapid development of new studies on BPA in the diet, it’s a good thing that FDA is taking another comprehensive look at the available science. In the development of their new assessment, FDA ought to use a “weight-of-the-evidence” approach to their work and give due consideration to each study’s funding source and the researchers’ freedom to design and publish their work without sponsor interference.
Full textFollowing up on Ben’s post about Tuesday’s Senate HELP Committee hearing on medical device preemption, I’d like to respond to three issues that came up during the question-and-answer session.
Innovation: Senators Harkin and Hatch had a bit of a disagreement about whether the possibility of tort liability stifles innovation by medical device firms. Peter Barton Hutt, who Senator Hatch lauded as the “dean of all FDA lawyers,” noted that he sits on the board of ten small biotech firms and that “decisions made by venture capitalists based upon such issues as potential liability directly affect every one of those companies.”
Two points here. First, it is a good thing that investors take into account potential tort liability. In the context of FDA-approved medical devices, tort law simply ensures that companies are operating according to a duty of care defined by a standard of reasonableness. It is not a high bar for them to meet and as consumers we should expect companies to only develop and market products that meet that standard. Second, as CPR Member Scholar Tom McGarity told the committee, there is no strong empirical evidence to back up the anecdotal claims like those made by Mr. Hutt. In fact, almost all of the great innovation that has happened in the field of medical devices happened during a time (pre-Riegel) when the firms developing new devices were subject to potential tort liability. There is no reason to believe that a law overturning Riegel, which would put the medical device firms in the same situation they were in for decades, would suddenly make them more risk-averse than they were before.
Insurance: Senators Hatch and Burr brought up the argument that we need federal preemption to help staunch what they see as an abundance of frivolous lawsuits filed by greedy lawyers that are driving up insurance costs across the medical industry. But as Professor McGarity, CPR Member Scholar Doug Kysar, and former CPR Policy Analyst (now Assistant Professor at Loyola Law) Karen Sokol explained in a CPR white paper, rising malpractice insurance premiums have more to do with the insurance industry’s bad financial investments (among other things) than they do with having to pay claims to injured patients.
Full textLast Thursday, EPA announced (pdf) that they would reconsider a rule on monitoring lead in the air that was published in the waning days of the Bush Administration. I wrote about the original announcement, criticizing EPA for turning its back on children in neighborhoods like mine, where certain sources of airborne lead wouldn’t be monitored because of some questionable lobbying by the lead battery industry. Long story, short: After originally proposing and asking the public to comment on lead monitoring thresholds between 200 and 600 kilograms per year, EPA changed its mind at the last minute and finalized a rule requiring monitors only at sources of airborne lead with outputs above 1000 kilograms per year.
This is an important issue because airborne lead has well known adverse impacts on neurological development. In its recitation of the justifications for regulating lead, EPA notes that manifestations of lead neurotoxicity include sensory, motor, cognitive, and behavioral impacts. Lead has been linked to lower scores on IQ tests and negative impacts on attention, memory, learning, and visuospatial processing. In the understated language of a federal agency, “Poor academic skills and achievement can have ‘enduring and important effects on objective parameters of success in real life,’ as well as increased risk of antisocial and delinquent behavior.”
Of course, kids in my neighborhood weren’t the only ones EPA would have been neglecting under the Bush-era rule, so back in January representatives of several local, state, and national organizations formally requested that EPA reconsider the rule. Their request shows, in stark terms, the struggle between OMB’s politically driven staff and EPA decisionmakers who were dutifully working to protect the public health. In one exchange after OMB requested that EPA double the threshold for “source-oriented” monitors, EPA staff sent back an e-mail informing them “that if OMB wants a 1 ton threshold, it would have to provide a rationale for that point of view,” emphasizing that the rationale should be “a technical rationale, and not policy views.”
Full textCenter for Progressive Reform policy analyst Matthew Shudtz blogs on the Environmental Protection Agency's recent revisions to the Clean Air Act National Ambient Air Quality Standard for lead. The White House Office of Management and Budget pressured EPA to limit the number of lead monitoring stations, including one near Shudtz's South Baltimore neighborhood.
Full textOn March 9, President Obama announced a science integrity initiative aimed at taking the politics out of science. In his memorandum that day, he laid out the broad principles and instructed the director of the Office of Science and Technology Policy (OSTP) to “develop recommendations for Presidential action designed to guarantee scientific integrity throughout the executive branch” - and to have the recommendations within 120 days. John Holdren has since been confirmed as OSTP Director.
Yesterday, Tuesday July 7, was 120 days after March 9. But there’s been no announcement of what Holdren is recommending.
CPR scholars have written extensively about the clean science initiative, lauding the initial announcement, sending initial ideas to Holdren and asking him to open the process to public comment, and lauding the White House when they did just that. In May, we submitted our comments to OSTP with our full recommendations on science integrity.
Let’s hope Holdren's recommendations are almost ready and will be made available for public scrutiny soon.
While his colleagues (and former colleagues) jockey for the healthcare reform limelight, Rep. Frank Pallone is quietly busy making sure that, regardless of who pays for healthcare, the sick and injured will have safe and effective solutions to their problems. Last Thursday, Rep. Pallone held a hearing to assess FDA’s ability to properly oversee the medical device industry. The testimony outlined a troubling picture.
GAO has been closely monitoring FDA’s medical device program for years. On Thursday, Marcia Crosse, the head of the government watchdog’s health care division, testified about three serious shortcomings in FDA’s work. To begin, FDA isn’t necessarily reviewing high-risk devices according to the most stringent premarket review processes, meaning the devices might reach the market without adequate review of their inherent dangers, putting patients at increased risk. That problem leads to the second flaw GAO identified – FDA is overwhelmed by the adverse event reports submitted to the agency. Manufacturers, doctors, patients, and hospitals all inform the agency when medical devices are linked to patient injuries, but the sheer volume of these reports is too great for FDA to review. Finally, Crosse testified about FDA’s poor record of inspections on medical device manufacturing facilities. (Check out the recent ProPublica/Chicago Tribune article that highlights the tragic consequences of insufficient inspections.)
Crosse’s testimony was based in large part on a January report from GAO that provided thoughtful suggestions for how FDA might improve its work. I hate to sound like a broken record, but there’s one more thing Congress could do to promote medical device safety – restore the traditional role of state common law as a complement to FDA’s work. Since the Supreme Court decided in Riegel v. Medtronic last year that the Medical Devices Safety Act preempts state common law, patients injured by dangerous medical devices have lost an avenue for seeking compensation for their injuries. Preemption is a dangerous policy, particularly when FDA doesn’t have the capacity to do the job it needs to.
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This afternoon, Congressman Brad Miller (D-NC), Chairman of the House Science Committee’s Subcommittee on Investigations and Oversight, will hold a hearing on recent revisions to the IRIS assessment process. IRIS (the Integrated Risk Information System) is EPA’s premier database of toxicological profiles for dangerous chemicals. The profiles are used for everything from setting cleanup standards at Superfund sites to determining liability in toxic tort suits. The problem is, IRIS only contains profiles for 548 chemicals. On average, 700 new chemicals enter commerce each year. Because IRIS numbers can serve as a cornerstone in the risk assessment/risk management process, an extensive database would greatly benefit policymakers in their daily work to protect public health.
We wanted to see whether some well-known toxins are adequately covered in the IRIS database, so we looked at the number of hazardous air pollutants that are listed in the Clean Air Act but missing from IRIS. We found that 17 percent of the chemicals have no profile at all. More remarkably, for a full two-thirds of the chemicals listed in the Clean Air Act, there is no data point in the IRIS database for the most relevant toxicological value needed to devise controls for toxic air pollution – the inhalation reference concentration (full report, press release)
Full textThe Milwaukee Journal-Sentinel continued its impressive BPA reporting Sunday with disturbing revelations about former FDA political appointees' utter disregard for the agency's career scientists. Using the Freedom of Information Act, the Journal-Sentinel uncovered e-mails showing that high-level officials went to industry lobbyists for advice about new research on bisphenol A (BPA) before asking FDA career staff.
In one instance, the U.S. Food and Drug Administration's deputy director sought information from the BPA industry's chief lobbyist to discredit a Japanese study that found it caused miscarriages in workers who were exposed to it. This was before government scientists even had a chance to review the study.
"I'd like to get information together that our chemists could look at to determine if there are problems with that data in advance of possibly reviewing the study," Mitchell Cheeseman, deputy director of the FDA's center for food safety and applied nutrition, said in an e-mail seeking advice from Steven Hentges, executive director of the trade association's BPA group.
BPA is a chemical used to make clear and rigid plastics -- everything from water bottles to dental fillings to DVDs. Its ubiquity in commerce translates to pervasive levels of human exposure: it is found in the urine of 93 percent of Americans.
Full textOn May 9, at the conclusion of the Fourth Conference of the Parties (COP-4) to the Stockholm Convention, negotiators from around the world agreed to add nine chemicals to the list of persistent organic pollutants (POPs) that are too dangerous for international trade. It was an important step toward protecting the world community from toxic exposures, but it unfortunately highlights our country's inability to take a leading role in international environmental law.
How it works
In 2001, representatives of nations from across the globe met in Stockholm to negotiate a treaty that would eliminate the production, distribution, and use of the most dangerous chemicals in the world marketplace. They originally agreed to phase out DDT, PCBs, and ten other substances known as the "dirty dozen" because of their high toxicity, ability travel great distances in air or water, and tendency to bioaccumulate in the food chain.
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